Safety and Effectiveness of Resistance Exercise Training in Patients With Pompe Disease.

Completed · Not applicable

Conditions studied: Pompe Disease, Muscle Weakness

In brief

The purpose of this research study is to determine if exercise will help improve muscle strength, endurance, and quality of life in individuals with Pompe disease. This is a research study to further define the outcome of patients with Pompe disease treated with a combined diet and exercise therapy.

Key facts

Study ID

NCT02654886

Run by

University of California, Irvine

People needed

10

Starts

2015-10-01

Expected to finish

2019-09-24

Last updated by the study team

2019-09-26

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to fully consent to the protocol.
• Physically able to perform resistance exercises for 12 weeks.
• Patients with a confirmed diagnosis of Pompe disease.
• Age 16 years to 75 years.
• Currently receiving ERT.
• Patient on ERT for at least 1year.

You may not qualify if…

• Patients with no confirmed diagnosis of Pompe disease, either by GAA enzyme deficiency from any tissue and/or molecular testing revealing two GAA gene mutations
• Unable to walk or cycle
• Unable to consent to the study/ procedures
• Women who are pregnant or breastfeeding
• Heart disease
• Patients with any metal inside their body such as metallic clips used for vascular repairs and/or implanted devices such as cardiac pacemakers which would prevent them from doing the MRI.

Where it is running

• UCI ICTS (Institute for Clinical and Translational Science) — Irvine, California, United States

Full record on ClinicalTrials.gov

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